FDA approves Eylea prefilled syringe

The FDA has approved a chemistry, manufacturing and controls prior-approval supplement for the Eylea injection prefilled syringe, Regeneron announced in a press release.
The 2-mg, single-dose, sterilized prefilled Eylea (aflibercept) syringe, which requires fewer preparation steps compared with vials, is expected to be available by the end of the year.
“With eight pivotal phase 3 trials and millions of injections used around the world, Eylea sets a high bar for visual acuity and safety across multiple retinal diseases, including wet age-related macular degeneration and diabetic eye diseases,”

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